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Radicava/Edaravone

Edaravone is a drug sold under the names, Radicava or Radicut. Japan, South Korea, Canada, Switzerland, China, Indonesia, Thailand, Malaysia, Brazil and the United States have approved its use to treat people with Amyotrophic Lateral Sclerosis (ALS) or Motor Neuron Disease (MND).

Background

Intravenous (IV) edaravone (Radicut) has been used in Japan since 2001 for the acute treatment of neurological symptoms related to ischemic stroke. Based on its proposed mechanism of action, a Japanese clinician suggested edaravone may be effective in treating ALS/MND. This led Mitsubishi Tanabe Pharma America, the owners of Radicut, to examine this possibility in clinical trials.

Approved in:    Commercial Name:  
Australia Radicava® 
Brazil  Radicava® 
Canada  Radicava® injection 30 mg/100 mL 
Radicava Oral Suspension (ORS) 
Japan  Radicut® bag 30 mg/100 mL   

Radicut® ampule 30 mg/20 mL 

RADICUT® Oral Suspension 2.1% 
Indonesia   Radicava® IV concentrate solution for infusion 30 mg/20 mL 
Malaysia  Radicava® IV concentrate solution for infusion 30 mg/20 mL 
South Korea  Radicut® ampule 30 mg/20 mL 
Switzerland   Radicava® 30 mg/100 mL 
Radicava® oral suspension 
Thailand   Radicava® 
USA  Radicava® 30 mg/100 mL 
Radicava Oral Suspension (ORS) 

Proposed Mechanism of Action

Several studies have shown that edaravone may act as a free-radical scavenger (or antioxidant) and may protect cells from damage inflicted by oxidative stress, which is hypothesized to be one of the mechanisms causing neuronal toxicity in ALS/MND. Currently it remains unclear how edaravone may have an effect in ALS/MND and studies are ongoing. All other clinical trials using antioxidant compounds have been ineffective for treating ALS/MND to date.

Edaravone IV in Clinical Trials

Multiple clinical trials of edaravone (Radicut) in ALS/MND were conducted in Japan for more than a decade. An initial double-blind, placebo-controlled study (MC-186) demonstrated a trend towards benefit for those treated with edaravone, but this was not statistically significant. Follow up (post-hoc) analysis revealed that a subgroup of participants earlier in the disease appeared to benefit compared to those further progressed. A second double-blind, placebo-controlled clinical trial was conducted, enrolling only individuals with the earlier disease criteria observed to benefit in the previous study and a statistically significant benefit was observed, with a difference of 2.49 ALSFRS-r points between the active treatment and placebo groups over 24 weeks. These results led to approval of edaravone in several countries, notably by the United States FDA in 2017 as Radicava.

Since approval of IV Radicava, MT Pharma has created an oral suspension formulation, which was approved by the FDA as Radicava ORS and Health Canada as Radicava Oral Suspension in 2022. Further clinical trials demonstrated that the oral edaravone acts in an equivalent manner in the body, is safe and is well tolerated.

Another oral formulation of edaravone, TW001, was created by the company Treeway in The Netherlands. TW001, also called FAB122, was tested in a double-blind, placebo-controlled Phase 3 clinical trial across Europe, called the ADORE study, that did not demonstrate benefit versus placebo. It is unknown how comparable this form of edaravone is to the MT Pharma drug and more details are expected later in 2024. More information about the oral formulation of Radicava can be found here.

Dose and Administration

Administration of edaravone occurs as a 28-day cycle. Edaravone is administered via IV infusion of 60 mg over 60 minutes once daily for 14 days followed by 14-days of a treatment-free period, after which the cycle repeats with a change to edaravone only on 10 out of 14 days during the treatment period. RADICAVA ORS uses the same dosing regimen as RADICAVA IV and is administered orally via mouth or feeding tube with a 5mL syringe.

Reported Side Effects

Edaravone is generally safe and well tolerated at the recommended dose. Commonly reported adverse effects of edaravone IV administration include issues walking, bruising, headaches, fatigue, and constipation. Serious adverse events reported from these studies include respiratory disorders, dysphagia, pneumonia aspiration, and musculoskeletal disorders.

Edaravone should be administered and monitored under the care of a physician.

Current Status

Our understanding of edaravone as a treatment for ALS/MND is constantly evolving. There are conflicting results with some studies suggesting a small benefit while other studies show no benefit. As more information arises, the Alliance will attempt to keep this document updated with current learnings.

Disclaimer: Consult with your doctor to determine if edaravone/Radicava is an option for you. Always disclose your medical history, including any drugs, natural supplements, or herbal medicines currently being used. Your doctor will determine the right plan for your needs.

SOURCES

  • http://www.ncbi.nlm.nih.gov/pubmed/?term=Abe+K+et+al.+Amyotroph+Lateral+Scler+Frontotemporal+Degener+2014%3B+15%3A+610-7  
  • https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(17)30115-1/abstract  
  • https://pubmed.ncbi.nlm.nih.gov/32062193/  
  • https://www.als.org/navigating-als/living-with-als/fda-approved-drugs/edaravone#researchers  
  • https://pubmed.ncbi.nlm.nih.gov/36504406/ 
  • https://pubmed.ncbi.nlm.nih.gov/33955162/ 
  •  https://www.radicava.com/patient/understanding-radicava/#an-oral-form 

International Alliance of ALS/MND Associations
September 2024


The original language of communication is English and any translation cannot be guaranteed for accuracy of messaging.

Primary Sidebar

Approved Drugs

  • Nuedexta
  • Radicava/Edaravone
  • Riluzole/Tiglutik
  • Rozebalamin/Methylcobalamin
  • Tofersen/Qalsody

  • Conny van der Meijden, Diagnosed 2001,  ALS Netherlands

    Conny van der Meijden, Diagnosed 2001, ALS Netherlands

  • Guido De Mets, Belgium

    Guido De Mets, Belgium

  • Christian Bär, Germany

    Christian Bär, Germany

  • 727747090571358167

    727747090571358167

  • Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

    Feng Gin Sun, Diagnosed 2014 , Shaanxi ALS Association, China

  • Jo Knowlton and her dog, Scotland

    Jo Knowlton and her dog, Scotland

  • Brian Parsons

    Brian Parsons

  • Mike Small, Motor Neurone Disease (MND) Association, UK

    Mike Small, Motor Neurone Disease (MND) Association, UK

  • Timothy Holman, Switzerland

    Timothy Holman, Switzerland

  • Jorge Melo, ABrELA, Brazil

    Jorge Melo, ABrELA, Brazil

  • Lachlan Terry,  MND Australia,  Diagnosed 2015

    Lachlan Terry, MND Australia, Diagnosed 2015

  • John and Loretta Russo, USA

    John and Loretta Russo, USA
    final3878

  • Antonio Ventriglia,  ALS Liga Belgium,  Diagnosed 2013

    Antonio Ventriglia, ALS Liga Belgium, Diagnosed 2013

  • Andrietta

    Andrietta

  • Hanne Stenmose, Muskelsvindfonden, Denmark

    Hanne Stenmose, Muskelsvindfonden, Denmark

  • David Bishop

    David Bishop

  • 393647_2252248542053_984912751_n

    393647_2252248542053_984912751_n

  • Peng Yi-Wen

    Peng Yi-Wen

  • Zabun Nassar, MND Association, Diagnosed 2016, England

    Zabun Nassar, MND Association, Diagnosed 2016, England

  • Francisco Perez Palop, Diagnosed 2013 , FUNDELA, Spain

    Francisco Perez Palop, Diagnosed 2013 , FUNDELA, Spain

  • Anita Forte, Les Turner ALS Foundation, USA

    Anita Forte, Les Turner ALS Foundation, USA

  • Cassio Fernando da Silva, Diagnosed 2013 , ABrELA, Brazil

    Cassio Fernando da Silva, Diagnosed 2013 , ABrELA, Brazil

  • Camilla Heiberg Freiberg, Muskelsvindfonden, Denmark

    Camilla Heiberg Freiberg, Muskelsvindfonden, Denmark

  • IMG_1211

    IMG_1211

  • Ali Var, Turkey

    Ali Var, Turkey

  • Alberto Baez Murillo, Colombia

    Alberto Baez Murillo, Colombia

  • Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

    Lucy Lintott, Diagnosed 2013 , MND Scotland, UK

  • IMG_2658

    IMG_2658

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Erwin Coppejans, Diagnosed 2007 , ALS Liga België, Belgium

    Erwin Coppejans, Diagnosed 2007 , ALS Liga België, Belgium

  • Laurie Petit-Jean, Diagnosed 2012 , ARSLA, France

    Laurie Petit-Jean, Diagnosed 2012 , ARSLA, France

  • Wendy Hendrickson, ALS Hope Foundation, USA

    Wendy Hendrickson, ALS Hope Foundation, USA

  • Bjarne Hytjanstorp, ALS Norge, Norway

    Bjarne Hytjanstorp, ALS Norge, Norway

  • Marco Antonio Alvarez Mercado, Mexico

    Marco Antonio Alvarez Mercado, Mexico

  • Fabrice Kamp, Germany

    Fabrice Kamp, Germany

  • Kirsten Harley,  Diagnosed 2013,  Australia

    Kirsten Harley, Diagnosed 2013, Australia

  • Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

    Alfredo Santos, Diagnosed 2013 , ACELA, Colombia

  • Sébastien Batiot, Diagnosed 2012 , ARSLA, France

    Sébastien Batiot, Diagnosed 2012 , ARSLA, France

  • Frank "Papa" Taylor, USA

    Frank “Papa” Taylor, USA

  • Ada Garrido Benavidez, Diagnosed 2016,  FYADENMAC, Mexico

    Ada Garrido Benavidez, Diagnosed 2016, FYADENMAC, Mexico

  • Armando González Gómez, ACELA, Colombia

    Armando González Gómez, ACELA, Colombia

  • Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

    Fabio Carvalho, Associação Pró-Cura da ELA, Brazil

  • Claire Garry, USA

    Claire Garry, USA
    20200117_214643

  • Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

    Sharon Corosanite, Diagnosed 2014 , ALS Hope Foundation, USA

  • Len Johnrose,  MND Association,  Diagnosed 2017,  England

    Len Johnrose, MND Association, Diagnosed 2017, England

  • Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

    Emilienne Verhaegen, ALS Liga Belgium, Diagnosed 2014

  • Irene McCaughey, Diagnosed 2011,  MND Australia

    Irene McCaughey, Diagnosed 2011, MND Australia

  • Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

  • Joy Blakeley, Diagnosed 2017 , MND Australia

    Joy Blakeley, Diagnosed 2017 , MND Australia

  • Tammy Moore and Eddy Lefrancois

    Tammy Moore and Eddy Lefrancois

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